Kinneret Savitsky, Ph.D., CEO of BioLineRx, remarked, “2014 marks a year of significant progress for BioLineRx on multiple fronts, both from a product development perspective, as well as from a business perspective. We have continued our focus on the therapeutic areas of oncology and immunology, while increasing the emphasis on our clinical-stage programs.”

“During the past year, we significantly enhanced and expanded the development strategy for our unique BL-8040 cancer therapy platform across a variety of hematological indications. Results to date from our ongoing Phase 2a clinical study of BL-8040 in relapsed and refractory AML patients continue to show substantial mobilization of leukemic cells from the bone marrow and robust induction of cancer cell apoptosis, as well as excellent safety and tolerability.
Top-line results from this study are expected in the second half of 2015. BL-8040 is also in the midst of a Phase 1 safety and efficacy study in stem cell mobilization, with top-line results expected by the end of this month. We eagerly await the data from both of these important studies. In addition, we recently expanded our clinical strategy for BL-8040 to include new clinical trials in three additional hematological indications, all of which are expected to commence by the end of the second quarter of this year. We look forward to executing our comprehensive development plan for this promising treatment platform and to reaching several meaningful value inflection points during 2015.”

“With regard to BL-7010, our product for the treatment of celiac disease, we are very pleased with the positive results we reported for the Phase 1/2 safety study completed in the fourth quarter of 2014, including the determination of the optimal safe dose for continued development. We are also very encouraged that the results further support previous preclinical data showing that BL-7010 is not absorbed systemically, which will likely support a medical-device classification and an expedited development pathway for the product in Europe. We are now conducting additional non-clinical studies and formulation development for BL-7010 in preparation for the upcoming efficacy study, which we plan to initiate in the second half of this year.”

“In December 2014, our partner Bellerophon reached a significant milestone in the development of BL-1040 for the prevention of ventricular remodeling following AMI – the completion of enrollment in the large CE Mark registration trial that has been ongoing for the past three years. We look forward to the top-line results from this trial, expected in mid-2015.”

“During the fourth quarter of 2014, we announced two significant business development achievements. First and foremost, we entered into a multi-year strategic collaboration with Novartis for the screening and co-development of therapeutic candidates through clinical proof-of-concept. As part of the collaboration, Novartis made an equity investment in BioLineRx of $10 million. We are very excited about the future potential of this collaboration, and view it as a strong validation of our core competencies by a world leader in our industry. In addition, we also announced the out-licensing to Omega Pharma of BL-5010, our skin lesion product, which we hope will begin to provide a royalty stream to us beginning in 2016.”

“Following the successful completion of our $29 million follow-on public offering earlier this month, we have a strong balance sheet, with enough cash to carry out our operating plan for at least the next three years. We expect to reach multiple significant catalysts during this period of time, both in the short term during 2015, as well as in 2016 and 2017.”